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A multi-center randomized controlled clinical trial of laparoscopic precision functional sphincter-preserving surgery for ultra-low rectal cancer based on a screw-thread anal dilator

A multi-center randomized controlled clinical trial of laparoscopic precision functional sphincter-preserving surgery for ultra-low rectal cancer based on a screw-thread anal dilator

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023038
Enrollment
Unknown
Registered
2019-05-08
Start date
2019-08-01
Completion date
Unknown
Last updated
2019-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ultra-low rectal cancer

Interventions

group control:performing traditional surgery
group PPS:performing precision functional sphincter-preserving NOSES surgery (PPS)

Sponsors

Department of Gastrointestinal Surgery, Shanghai Tenth People's Hospital, School of Medicine, Tongji University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. The patients are diagnosed with rectal cancer and going to perform surgery ;the lower edge of the tumor is less than 6cm from the anal margin; 2. The tumor has no distant metastasis, and the clinical T stage of the tumor is less than or equal to 3, the M stage of the tumor is 0; 3. Age between 18-75 years old; 4. Subjects or guardians voluntarily participate in the experiment and sign informed consent before entering the study.

Exclusion criteria

Exclusion criteria: 1. Patients with other malignant tumors; 2. Patients with severe heart, lung, liver and kidney dysfunction, abnormal blood coagulation, severe hypertension, diabetes; 3. Patients with disturbance of consciousness or mental illness; 4. Special conditions taboos: pregnant, breast-feeding, infected, eating difficulties, can not cooperate with patients.

Design outcomes

Primary

MeasureTime frame
probability of anal sphincter preservation;the function of the anal;the probability of tumor recurrence;

Secondary

MeasureTime frame
operation time;intraoperative bleeding volume;length of hospital stay after operation;quality of Life;

Countries

China

Contacts

Public ContactLiu Zhongchen

Department of Gastrointestinal Surgery, Shanghai Tenth People's Hospital, School of Medicine, Tongji University

13860184888@163.com+86 13860184888

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026